Abstract
Background: Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods: Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results: A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13-20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions: DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.
| Original language | English |
|---|---|
| Article number | 21 |
| Journal | AIDS Research and Therapy |
| Volume | 16 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Aug 26 2019 |
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Keywords
- Adverse events
- CISAI
- Darunavir/cobicistat
- Dual
- Durability
- Tolerability
ASJC Scopus subject areas
- Molecular Medicine
- Virology
- Pharmacology (medical)
Cite this
Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life : Results from a large multicentre observational prospective cohort (SCOLTA). / on behalf of CISAI Study Group ; Taramasso, L.; Ricci, Elena; Cascio, Antonio; Valsecchi, Laura; Menzaghi, B.; Squillace, N.; Maggi, Paolo; De Socio, G. V.; Dentone, Chiara; Madeddu, G.; Pellicanò, Giovanni F.; Calza, L.; Angioni, Goffredo; Bonfanti, Paolo; Di Biagio, Antonio.
In: AIDS Research and Therapy, Vol. 16, No. 1, 21, 26.08.2019.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life
T2 - Results from a large multicentre observational prospective cohort (SCOLTA)
AU - on behalf of CISAI Study Group
AU - Taramasso, L.
AU - Ricci, Elena
AU - Cascio, Antonio
AU - Valsecchi, Laura
AU - Menzaghi, B.
AU - Squillace, N.
AU - Maggi, Paolo
AU - De Socio, G. V.
AU - Dentone, Chiara
AU - Madeddu, G.
AU - Pellicanò, Giovanni F.
AU - Calza, L.
AU - Angioni, Goffredo
AU - Bonfanti, Paolo
AU - Di Biagio, Antonio
PY - 2019/8/26
Y1 - 2019/8/26
N2 - Background: Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods: Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results: A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13-20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions: DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.
AB - Background: Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods: Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results: A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13-20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions: DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.
KW - Adverse events
KW - CISAI
KW - Darunavir/cobicistat
KW - Dual
KW - Durability
KW - Tolerability
UR - http://www.scopus.com/inward/record.url?scp=85071637093&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85071637093&partnerID=8YFLogxK
U2 - 10.1186/s12981-019-0236-0
DO - 10.1186/s12981-019-0236-0
M3 - Article
C2 - 31451115
AN - SCOPUS:85071637093
VL - 16
JO - AIDS Research and Therapy
JF - AIDS Research and Therapy
SN - 1742-6405
IS - 1
M1 - 21
ER -